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The drug authorisation process was introduced in the 1960s to ensure that only quality drugs with proven safety and efficacy enter the market.1 The process was introduced as a response to adverse drug reactions that occurred, in particular, in adults, and also after the chloramphenicol and thalidomide tragedies that occurred in newborn infants. The procedures, initially defined by the Food and Drug Administration and later also by other national and European regulatory agencies, were improved over time. In general, when a pharmaceutical company submits an application to the licensing authority, safety and efficacy data originating mainly from formal clinical trials have to be provided. However, this is not always the case with children, who are routinely given drugs in an ‘off-label’ manner, as was documented for the first time in Europe in the 1980s.2

Although the precise definitions have changed from author to author and over time, in general, off-label drug use is the practice of prescribing drugs outside their authorised indications with respect to dosage, age, indication or route, and unlicensed drugs are those that are prepared as extemporaneous preparations, which are imported or used before an authorisation (license) is granted, or are chemicals …

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